COVID-19
Conditions
Keywords
COVID-19 booster vaccine hesitancy, Educational intervention, COVID-19
Brief summary
The purpose of this study is to recruit a total of 386 participants to evaluate the effectiveness of an educational program to increase the proportion of men and women aged 21 years and older who have received the COVID-19 booster vaccine
Detailed description
This study will address vaccine hesitancy, evaluating the intervention's efficacy in a group of vulnerable and economically disadvantaged population in PR. Randomized Clinical Trial (study design) to evaluate the effectiveness of an educational intervention to increase vaccine uptake among socioeconomically disadvantaged adults. A total sample of 386 participants will be recruited. The duration of the study will consist of 1.5 hours for intervention group and 1 hour for control group. Eligibility criteria for the study include the following: (1) age 21 years and older, (2) resident of Puerto Rico, (3) to be fully vaccinated (received the one-dose Jansen/Johnson & Johnson vaccine, -OR- received both doses of the two-dose Pfizer or Moderna vaccine), have not received booster doses against COVID-19, (4) no history of allergic reactions to any vaccine, (5) no history of mental health conditions that impede participation in the study, and (6) able to read, write, and understand Spanish.
Interventions
OTHEREducational intervention
Randomized Clinical Trial (study design) to evaluate the effectiveness of an educational intervention to increase vaccine uptake among socioeconomically disadvantaged adults. The intervention will consist of a health promoter with an educational toolkit addressing misinformation, distrust, and hesitancy regarding the COVID-19 vaccine. An educational website with videos addressing COVID-19 vaccine will be available to study participants to boost information provided in the educational toolkit.
Sponsors
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
University of Puerto Rico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
The participants will not be aware if they are assigned to an educational intervention nor control group. All will be assessed equally.
Intervention model description
Participants are assigned to one of two groups in parallel for the duration of the study. 193 participants will be assigned to an educational intervention group and 193 will be assigned to a control group.
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. age 21 years and older 2. resident of Puerto Rico 3. to be fully vaccinated (received the one-dose Jansen/Johnson & Johnson vaccine, -OR- received both doses of the two-dose Pfizer or Moderna vaccine) 4. have not received booster doses against COVID-19 5. no history of allergic reactions to any vaccine, 6. no history of mental health conditions that impede participation in the study 7. able to read, write, and understand Spanish.
Exclusion criteria
1. age 20 years and younger 2. not a resident of Puerto Rico 3. not to be fully vaccinated (have not received the one-dose Jansen/Johnson & Johnson vaccine, -OR- have not received both doses of the two-dose Pfizer or Moderna vaccine) 4. have received booster doses against COVID-19 5. history of allergic reactions to any vaccine, 6. history of mental health conditions that impede participation in the study 7. not be able to read, write, and understand Spanish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of COVID-19 vaccine completion | Up to 4 months | The investigators will record the vaccine brand of primary (Pfizer, Moderna, or Johnson & Johnson) and capture the vaccine administration's completion (if necessary). |
| Rate of COVID-10 booster vaccine uptake | Up to 4 months | The investigators will capture the booster vaccine administration and record the vaccine brand (Pfizer, Moderna, or Johnson & Johnson). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant's willingness to get vaccinated against COVID-19 | Up to 4 months | Willingness to vaccinate against COVID-19 (vaccine confidence, vaccine convenience, vaccine complacency, and vaccine attitudes and beliefs), and receive the physician's recommendation to be vaccinated |
| Educational tool utilization by the participants | Up to 4 months | Evaluate if participant read the educational tool |
Countries
Puerto Rico
Outcome results
None listed